Senior Validation Engineer (Pharma Manufacturing)

Job Description : Senior Validation Engineer

Work Location : East Windsor, NJ(Onsite)

Position Summary :

Validation Engineer Ill ensures compliance by validating systems, equipment, and processes while managing the lifecycle of Computer System Validation and cross-departmental projects. This role drives technical transfers, leads continuous improvement initiatives, and supports audits to enhance efficiency and maintain regulatory standards.

Key Responsibilities :

• Ensures compliance by validating facilities, equipment, systems, and processes while authoring and approving commissioning and validation documents for sterile and non-sterile manufacturing.
• Manages the lifecycle of Computer System Validation, executes multiple protocols, and analyzes data to create reports, including deviations.
• Coordinates cross-departmental validation activities, tracks timelines and budgets, and drives technical transfers across Empower sites.
• Leads continuous improvement through quality investigations, Corrective and Preventive Actions, Risk Assessments, Change Control, and staff training.
• Provides expertise during audits, manages contractors for Commissioning, Qualification, and Validation (CQV), and develops cleaning, sterilization, and process cycles.
• While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices.
• The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl.

Mandatory Qualifications :